Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy

This study is ongoing, but not recruiting participants.

First Received: October 25, 2007 Last Updated: October 21, 2008 History of Changes

Sponsors and Collaborators:	Kuhnil Pharmaceutical Co., Ltd. Pronova BioPharma ASA
Information provided by:	Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00549692

Purpose

The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy

Condition	Intervention	Phase
IGA Nephropathy	Drug: Omega-3 fatty acid ethylester90	Phase III

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Minimization, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy

Further study details as provided by Kuhnil Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

The rate of number of patients that 50% or more increase in SCr after 24 months [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of number of patients that 50% or more increase in SCr after 6 and 12 months [ Time Frame: Two years ] [ Designated as safety issue: No ]
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Omega-3 fatty acid ethylester90 Dosage form :1g soft capsule Dosage : two capsules, twice a day.
2: Placebo Comparator	Drug: Omega-3 fatty acid ethylester90 Dosage form :1g soft capsule Dosage : two capsules, twice a day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient of both sexes age 18 or above
Biopsy-proven IgA nephropathy
Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male)
Able to give written informed consent

Exclusion Criteria:

Hypertension SBP>160mmHg and/or DBP>100mmHg
Subject, who in the investigator's opinion, has a systemic disease that would contraindicate participation in this study
Use of omega-3 fatty acids or analog supplement
Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception
Current or recent (within 30 days) exposure to any investigational drug
Subject who has hypersensitivity to this agent as a previous illness
Low platelet(<100,000/㎕) or the subject who has a high risk of bleeding
Use of corticosteroid during the treatment period or less than 3 months prior to the screening
Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening
Subject who in the investigator's opinion, would be confronted with a difficulty

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549692

Locations

Korea, Republic of
Kyhung Hee University medical center
Seoul, Korea, Republic of, 130-702
Kangnam St. May's Hospital
Seoul, Korea, Republic of, 137-701
Samsumg Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-740
Korea, Republic of, Kyeonggi-do
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, Korea, Republic of, 463-707

Sponsors and Collaborators

Kuhnil Pharmaceutical Co., Ltd.

Pronova BioPharma ASA

Investigators

Study Chair:	Suhnggwon Kim, Professor	Seoul National University Hospital
Principal Investigator:	Byung-Joo Park, MD,PhD,FISPE	Seoul National University College of Medicine

More Information

No publications provided

Responsible Party:	Kuhnil Pharmaceutical Co., Ltd. ( Dong-Jae Choi/Executive Director )
Study ID Numbers:	06-OM-8301
Study First Received:	October 25, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00549692 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA); South Korea: Institutional Review Board

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Nephritis

Glomerulonephritis, IGA
Kidney Diseases
Berger Disease

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Urologic Diseases

Nephritis
Glomerulonephritis, IGA
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009